MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK SUPERA

Device Problems Stretched (1601); Defective Device (2588); Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of implant estimated as (b)(6) 2023.D4: the udi is unknown because the part/lot numbers were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot numbers were not provided.The investigation determined a conclusive cause for the reported stretched-stent, the reported patient-device incompatibility-recoil and the reported defective device-shortened cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The reported adverse patient effects referenced in b5 are being filed under a separate medwatch report #.Attachment: article titled, 'a systematic review and meta-analysis of supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease'na.

Event Description

It was reported through a research article identifying supera that may be related to the following: stenosis, occlusion, dissection, elongation, compression, malapposition, invagination, and amputation.This is a systematic review for articles published from december 2011 up to may 2021 regarding studies assessing the safety and efficacy of supera interwoven nitinol stent for the treatment of infra-inguinal peripheral artery disease.Details are in the attached article titled, "a systematic review and meta-analysis of supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease".

• Brand Name: SUPERA
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18312639
• MDR Text Key: 330298500
• Report Number: 2024168-2023-13844
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1